(154 days)
No
The summary describes a manual, disposable device for measuring and regulating cuff pressure, with no mention of AI, ML, or related concepts.
No
The device is intended to measure and regulate cuff pressure, which is a monitoring and maintenance function, not a direct therapeutic intervention on the patient.
No
The device measures and regulates intra-cuff pressure, which is a monitoring and management function rather than a diagnostic one. While the information from the device can be used in patient care decisions, its primary purpose is not to diagnose a disease or condition.
No
The device description explicitly states it is a "disposable, hand-held measuring device," indicating it is a physical hardware device, not software only.
Based on the provided information, the VORTRAN® Cuff Inflator (VCI) is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to "measure and regulate the intra-cuff pressure of Endotracheal tubes, Tracheostomy tubes and Laryngeal Mask Airways (LMAs)." This involves interacting with a medical device (the tube/airway) and the patient's airway, not analyzing biological samples (like blood, urine, tissue) outside the body.
- Device Description: The description reinforces its function as a "hand-held measuring device intended to measure and manually regulate intra-cuff pressure." Again, this is a physical measurement and regulation task, not a diagnostic test performed on a sample.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, chemical reactions, or diagnostic assays, which are hallmarks of IVD devices.
Therefore, the VORTRAN® Cuff Inflator (VCI) is a medical device used for monitoring and managing the pressure within airway cuffs, not for performing in vitro diagnostic tests.
N/A
Intended Use / Indications for Use
The VORTRAN® Cuff Inflator (VCI) is intended to measure and regulate the intra-cuff pressure of Endotracheal tubes, Tracheostomy tubes and Laryngeal Mask Airways (LMAs). The VORTRAN® Cuff Inflator (VCI) is used under medical supervision in hospitals, pre-hospital (EMS), extended care facilities, and outpatient clinics, where a patient may be intubated.
Product codes
BSK
Device Description
The VORTRAN® Cuff Inflator (VCI) is a disposable, hand-held measuring device intended to measure and manually regulate intra-cuff pressure of Endotracheal, Tracheostomy, and LMA tubes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Used under medical supervision in hospitals, pre-hospital (EMS), extended care facilities, and outpatient clinics.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Performance testing included manometer accuracy, inflation and deflation functions, and absence of leaks. The performance testing includes a comparison between the VORTRAN® Cuff Inflator (VCI) and its predicate and reference devices, Posey Cufflator and Hospitech AG Cuffill.
Key Metrics
Pressure Range of Device: 0-60 cm-H2O
Accuracy of Cuff Pressure Measurement: ± 3 cm-H2O within the typical operating range of 20 – 40 cm-H2O
Predicate Device(s)
Reference Device(s)
K122721, K142103, K153733, K041473
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5750 Inflatable tracheal tube cuff.
(a)
Identification. An inflatable tracheal tube cuff is a device used to provide an airtight seal between a tracheal tube and a patient's trachea.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services logo. The logo on the right is the FDA logo, which is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 25, 2018
VORTRAN Medical Technology 1, Inc. James Lee Executive Vice President & COO 21 Goldenland Court #100 Sacramento, California 95834
Re: K173914
Trade/Device Name: VORTRAN Cuff Inflator (VCI) Regulation Number: 21 CFR 868.5750 Regulation Name: Inflatable Tracheal Tube Cuff Regulatory Class: Class II Product Code: BSK Dated: April 13, 2018 Received: April 18, 2018
Dear James Lee:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael J. Ryan -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
VORTRAN® Cuff Inflator (VCI)
Indications for Use (Describe)
The VORTRAN® Cuff Inflator (VCI) is intended to measure and regulate the intra-cuff pressure of Endotracheal tubes, Tracheostomy tubes and Laryngeal Mask Airways (LMAs). The VORTRAN® Cuff Inflator (VCI) is used under medical supervision in hospitals, pre-hospital (EMS), extended care facilities, and outpatient clinics, where a patient may be intubated.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
I. SUBMITTER
VORTRAN Medical Technology 1, Inc. 21 Goldenland Court, Suite 100 Sacramento, CA 95834 USA
Phone: (800) 434-4034 Fax: (916) 648-9751
Contact Person: James Lee Date Prepared: May 25, 2018
II. DEVICE
Name of Device: VORTRAN® Cuff Inflator (VCI) Common or Usual Name: Endotracheal cuff pressure regulator Classification Name: Cuff, Tracheal Tube, Inflatable Regulation Number: 21 CFR 868.5750 Regulatory Class: II Product Code: BSK Classification Advisory Committee: Anesthesiology Review Advisory Committee: Anesthesiology
III. PREDICATE AND REFERENCE DEVICE
| K912723 | Posey Cufflator (Predicate Device) |
|---|---|
| K122721 | Hospitech AG Cuffill (Reference Device) |
| K142103 | Teleflex Medical CUFF PILOT, SURE SEAL (Reference Device) |
| K153733 | VORTRAN® Manometer (Reference Device - For Material Compatibility Only) |
| K041473 | VORTRAN® Automatic Resuscitator (VAR-Plus) (Reference Device - For Material Compatibility Only) |
DEVICE DESCRIPTION IV.
The VORTRAN® Cuff Inflator (VCI) is a disposable, hand-held measuring device intended to measure and manually regulate intra-cuff pressure of Endotracheal, Tracheostomy, and LMA tubes.
4
510(k) Summary – VORTRAN® Cuff Inflator (VCI)
K173914/S002
INDICATIONS FOR USE V.
The VORTRAN® Cuff Inflator (VCI) is intended to measure and regulate the intra-cuff pressure of Endotracheal tubes. Tracheostomy tubes and Laryngeal Mask Airways (LMAs). The VORTRAN® Cuff Inflator (VCI) is used under medical supervision in hospitals, pre-hospital (EMS), extended care facilities, and outpatient clinics, where a patient may be intubated.
INTENDED POPULATION VI.
Intubated patients
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS VII. WITH THE PREDICATE DEVICE
The tables below show the technological differences and similarities of our VORTRAN® Cuff Inflator (VCI) compared to the predicate devices.
| NEW DEVICE | PREDICATE DEVICE | REFERENCE DEVICE | |
|---|---|---|---|
| Device Name | VORTRAN® Cuff Inflator (VCI) | Posey Cufflator | Hospitech AG Cuffill |
| 510(k) Number | K173914/S002 | K912723 | K122721 |
| Technology | Inflation - Bellows pump | ||
| Measurement - Mechanical gauge | |||
| Same as predicate device | Inflation - Bellows pump | ||
| Measurement - Mechanical gauge | Inflation - Syringe plunger | ||
| Measurement - Electronic Pressure | |||
| Sensor | |||
| Method of Inflating | |||
| Cuff | Manually press bellows pump | ||
| Same as predicate device | Manually press bellows pump | Manually press syringe plunger | |
| Method of | |||
| Deflating Cuff | Manually press air vent button | ||
| Same as predicate device | Manually press air vent button | Manually pull out syringe plunger | |
| Attaches to Cuff | |||
| Inflation Pilot | Via male Luer fitting | ||
| Same as predicate devices | Via male Luer fitting | Via male Luer fitting | |
| Types of airways to | |||
| which it can be | |||
| used | Endotracheal tubes, tracheostomy | ||
| tubes, and Laryngeal Mask Airways | |||
| (LMAs) | |||
| Same as predicate devices | Endotracheal tubes or tracheal | ||
| tubes | Endotracheal tubes, tracheotomy tubes, | ||
| and Laryngeal Mask Airways (LMAs) |
Operational Characteristics:
5
510(k) Summary – VORTRAN® Cuff Inflator (VCI)
K173914/S002
Pressure Accuracy and Range:
| | NEW
DEVICE | PREDICATE
DEVICE | REFERENCE
DEVICE | REFERENCE
DEVICE |
|----------------------------------------------|-----------------------------------------------------------------------|---------------------|-------------------------|-------------------------------|
| Device Name | VORTRAN® Cuff Inflator (VCI) | Posey Cufflator | Hospitech AG
Cuffill | SureSeal™ with
Cuff Pilot™ |
| 510(k) Number | K173914/S002 | K912723 | K122721 | K142103 |
| Pressure Range of Device (1) | 0-60 cm-H2O | 0-120 cm-H2O | 0-99 cm-H2O | 0-80 cm-H2O |
| Accuracy of Cuff Pressure
Measurement (1) | ± 3 cm-H2O within the typical
operating range of
20 – 40 cm-H2O | ± 2 cm-H2O | ± 2 cm-H2O | ± 5 cm-H2O |
(1) range has no significant difference, in comparison to its predicate or reference devices, and does not raise different questions of safety and effectiveness.
Physical Characteristics:
| NEW DEVICE | PREDICATE DEVICE | REFERENCE DEVICE | |
|---|---|---|---|
| Device Name | VORTRAN® Cuff Inflator (VCI) | Posey Cufflator | Hospitech AG Cuffill |
| 510(k) Number | K173914/S002 | K912723 | K122721 |
| Size | 3 in. x 2 in. x 1.8 in. | None specified | Length: 7.87 in. |
| Diameter (ID): 0.59 in. |
Material of Construction:
The VORTRAN® Cuff Inflator (VCI) uses the same materials as predicate devices manufactured by VORTRAN Medical. The following table lists the component name, their material, cleared device name, and 510k Number/Date.
| | NEW DEVICE | REFERENCE DEVICE
FOR MATERIAL ONLY | REFERENCE DEVICE
FOR MATERIAL ONLY |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|-----------------------------------------------|
| Device Name | VORTRAN® Cuff Inflator (VCI) | VORTRAN® Manometer | VORTRAN® Automatic
Resuscitator (VAR-Plus) |
| 510(k) Number | K173914/S002 | K153733 | K041473 |
| Date SE Decision | N/A | September 16, 2016 | July 15, 2004 |
| All Plastic Components: Body, Pump
Enclosure, Pump Seal Disk, Pump
Spring Cap, Pump Lock Ring,
Release Enclosure, Release Seal
Disc, Release Spring Cap | Polycarb
Same as reference device
(VORTRAN® Manometer) | Manometer Top, Gear End Plate,
Tee Connector, Diaphragm
Support Disk, and Vertical
Connection:
Polycarb | N/A |
| All Rubber Components:
Pump, Quad Rings | Silicone
Same as reference devices | Diaphragm:
Silicone | Diaphragm:
Silicone |
| All Springs:
Pump Spring, Release Spring | Stainless Steel
Same as reference device
(VORTRAN® Automatic
Resuscitator VAR-Plus) | N/A | Internal Springs:
Stainless Steel |
| Manometer Assembly: | Entire assembly identical to
reference device (VORTRAN®
Manometer) | All materials and components
cleared under 510(k) No.
K153733 | N/A |
6
VIII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility Testing .
Neither the VORTRAN® Cuff Inflator (VCI), nor the air pumped from it, comes in direct or indirect contact with the patient or the user. Therefore, as per ISO 10993-1, there is no requirement for the VORTRAN® Cuff Inflator (VCI) components or its materials to be tested for biocompatibility.
-
Animal Study ●
N/A -
Clinical Studies None
. Non-Clinical Performance Data
Performance testing included manometer accuracy, inflation and deflation functions, and absence of leaks. The performance testing includes a comparison between the VORTRAN® Cuff Inflator (VCI) and its predicate and reference devices, Posey Cufflator and Hospitech AG Cuffill.
● Clinical Application
The VORTRAN® Cuff Inflator (VCI) connects to cuffed tubes (via a Luer fitting), which are used in applications in which a patient is intubated.
Compliance with Performance Standards ● None
CONCLUSIONS IX.
The VORTRAN® Cuff Inflator (VCI) is substantially equivalent to predicate devices: Posey Cufflator (primary) and reference devices: Hospitech AG Cuffill, VORTRAN® Manometer (material only), and VORTRAN® Automatic Resuscitator (VAR-Plus) - (material only). The VORTRAN® Cuff Inflator (VCI) is concluded to not raise any different questions of safety and effectiveness in comparison to its predicate devices.